# K023062: Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain Management

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories, Inc.
- Decided: Sep 30, 2002 after 14 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
36 later devices descend from it; 4 cite it directly.
9 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott GemStarTM I.V. Infusion Pump: named in the summary without a submission number

## Most influential descendants
- K051079: Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring Assist Mechanism Lockbox-7 Therapy (2005), 30 descendants of its own
- K061110: Glucommander Plus (2006), 16 descendants of its own
- K101344: G+ System (2010), 13 descendants of its own
- K041550: Hospira Phoenix Infusion System with Hospira Mednet Software (2004), 13 descendants of its own
- K113853: G+ System (2012), 12 descendants of its own

## Recalls of this device
- Mar 28, 2012 · Not classified · Z-1463-2012: Hospira has received customer reports of bolus delivery failures when using the GemStar bolus cord. Possible failures may be a result of cracked or damaged bolus cords which may result in an open or s

## Indications for use
The Abbott Gemstar@Infusion Pump System has the following indications for use: The Abbott Gemstar@Infusion Pump is intended for use in intravenous arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.

Source page: https://510kreport.com/device/K023062
Methodology: https://510kreport.com/methodology